---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-261706"
form_type: "8-K"
ticker: "RNTX"
cik: "0001420565"
company_name: "Rein Therapeutics, Inc."
filed_at: "2025-11-03T23:59:59+00:00"
generated_at: "2026-05-17T00:50:59.865756+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA lifts clinical hold on Rein Therapeutics' Phase 2 trial of LTI-03 for IPF

## Summary
- FDA lifted full clinical hold after Rein's Complete Response submission; agency confirmed all concerns resolved.
- Company expects to resume U.S. patient enrollment in late 2025 or early 2026 across ~20 clinical sites.
- Global Phase 2 RENEW trial to enroll up to 120 IPF patients; topline data expected in Q3 2026.
- LTI-03 aims to slow fibrosis and promote lung repair, per CEO Brian Windsor.

## SEC filing metadata
- accession: 0001193125-25-261706
- form_type: 8-K
- ticker: RNTX
- cik: 0001420565
- company_name: Rein Therapeutics, Inc.
- filed_at: 2025-11-03T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1420565/000119312525261706/0001193125-25-261706-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1420565/000119312525261706/d47241d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-261706
- JSON: https://secwatch.observer/filing/0001193125-25-261706.json
- Plain text: https://secwatch.observer/filing/0001193125-25-261706.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.